MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HABIB ENDOHPB; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00500070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cholangitis (4821)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e1109 captures the reportable patient complication of cholangitis.Impact code f2303 is being used to capture the antibiotic and fluid medications administered to the patient.Impact code f08 is being used to capture the patient's hospitalization.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr.Report #3005099803-2023-04100).It was reported to boston scientific corporation that an endohpb rf catheter was used, and an advanix biliary stent was implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct, performed on (b)(6) 2023.On (b)(6) 2023, at an outside hospital (osh) the patient presented with cholangitis.On (b)(6) 2023, the patient was admitted and was administered antibiotics and fluids during their stay.On (b)(6) 2023, the implanted advanix stent was successfully removed during an ercp procedure, and a new advanix biliary stent was placed.On (b)(6) 2023, the patient was discharged with continuous antibiotics.It is not known whether the advanix biliary stent (the subject of mfr.Report# 3005099803-2023-04100) or the endohpb rf catheter may have caused or contributed to the patient's complication of cholangitis.The patient is reported to be currently well in the context of having terminal cancer.

• Brand Name: HABIB ENDOHPB
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): STATICE MANUFACTURING; 9 rue thomas edison; besancon 25000 ; FR 25000
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17459629
• Report Number: 3005099803-2023-04097
• Device Sequence Number: 11489241
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K231533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2025
• Device Model Number: M00500070
• Device Catalogue Number: 2244-01
• Device Lot Number: 0585910010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown